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A Study of Fluzoparib Given in Combination With Apatinib and Paclitaxel in Gastric Cancer Patients

Primary Purpose

Recurrent and Metastatic Gastric Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Fluzoparib
Apatinib
Paclitaxel
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent and Metastatic Gastric Cancer focused on measuring PARP inhibitor, VEGFR inhibitor, Combination therapy, Gastric cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ECOG performance status of 0 to 1.
  • Life expectancy of more than 12 weeks.
  • Histologically or cytologically confirmed gastric adenocarcinoma( adenocarcinoma of the gastroesophageal junction included).
  • Recurrent or metastatic gastric cancer that has progressed following first line-therapy.
  • At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline
  • Subjects who have overall good overall general condition.
  • Signed informed consent.

Exclusion Criteria:

  • Subjects who received any previous treatment with any PARP inhibitors.
  • Subjects who received any previous treatment with any taxanes.
  • More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting.
  • Less than 4 weeks from the last clinical trial.
  • Less than 2 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment and target therapy.
  • Unstable hypertension.
  • Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.
  • Subjects with brain metastases.
  • Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
  • Subjects with a known hypersensitivity to fluzoparib, apatinib, paclitaxel or any of the excipients of the product.
  • Ongoing infection (determined by investigator).
  • History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  • Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
  • Pregnant or breast-feeding women.

Sites / Locations

  • The Affiliated Hospital of Military Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluzoparib + Apatinib + Paclitaxel

Arm Description

Outcomes

Primary Outcome Measures

DLT and safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis.
DLT and safety defined by CTC version 4.0

Secondary Outcome Measures

Best of ORR
Overall Response Rate (ORR)
Disease Control Rate (DOR)
Time to Progression (TTP)
Progression Free Survival (PFS)
Maximum plasma concentration (Cmax)
Terminal half life (t1/2)
Area under the plasma concentration-time curve (AUC）
Volume of distribution (V/F)
Plasma Clearance (CL/F)

Full Information

First Posted
December 21, 2016
Last Updated
March 5, 2017
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03026881
Brief Title
A Study of Fluzoparib Given in Combination With Apatinib and Paclitaxel in Gastric Cancer Patients
Official Title
An Open, Non-randomised, Multi-centre Phase I Study to Assess the Safety and Efficacy of Fluzoparib Given in Combination With Apatinib and Paclitaxel in the 2nd Line Treatment of Patients With Recurrent or Metastatic Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor; Apatinib is an oral selective VEGFR inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of Fluzoparib in combination with apatinib and paclitaxel and to see how well this three drugs work together in the treatment of patients with recurrent and metastatic gastric cancer who progress following first-line therapy. The safety and efficacy of fluzoparib in combination with apatinib and paclitaxel will be explored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent and Metastatic Gastric Cancer
Keywords
PARP inhibitor, VEGFR inhibitor, Combination therapy, Gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluzoparib + Apatinib + Paclitaxel
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fluzoparib
Other Intervention Name(s)
SHR3162
Intervention Description
Fluzoparib either at 20,30,40mg twice daily,capsule oral.
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Intravenous injection
Primary Outcome Measure Information:
Title
DLT and safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis.
Description
DLT and safety defined by CTC version 4.0
Time Frame
through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Best of ORR
Time Frame
through study completion, an average of 6 months
Title
Overall Response Rate (ORR)
Time Frame
through study completion, an average of 6 months
Title
Disease Control Rate (DOR)
Time Frame
through study completion, an average of 6 months
Title
Time to Progression (TTP)
Time Frame
From date of enrollment until the date of first objective progression, assessed up to 9 months
Title
Progression Free Survival (PFS)
Time Frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, an average of 6 months
Title
Maximum plasma concentration (Cmax)
Time Frame
Up to 33 days
Title
Terminal half life (t1/2)
Time Frame
Up to 33 days
Title
Area under the plasma concentration-time curve (AUC）
Time Frame
Up to 33 days
Title
Volume of distribution (V/F)
Time Frame
Up to 33 days
Title
Plasma Clearance (CL/F)
Time Frame
Up to 33 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ECOG performance status of 0 to 1. Life expectancy of more than 12 weeks. Histologically or cytologically confirmed gastric adenocarcinoma( adenocarcinoma of the gastroesophageal junction included). Recurrent or metastatic gastric cancer that has progressed following first line-therapy. At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline Subjects who have overall good overall general condition. Signed informed consent. Exclusion Criteria: Subjects who received any previous treatment with any PARP inhibitors. Subjects who received any previous treatment with any taxanes. More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting. Less than 4 weeks from the last clinical trial. Less than 2 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment and target therapy. Unstable hypertension. Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption. Subjects with brain metastases. Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry. Subjects with a known hypersensitivity to fluzoparib, apatinib, paclitaxel or any of the excipients of the product. Ongoing infection (determined by investigator). History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation. Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study. Pregnant or breast-feeding women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianming Xu, MD
Email
jmxu2003@yahoo.com
Facility Information:
Facility Name
The Affiliated Hospital of Military Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianming Xu, MD
Email
jmxu2003@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Study of Fluzoparib Given in Combination With Apatinib and Paclitaxel in Gastric Cancer Patients

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